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September 10, 2025

Features of the National Registration of Medical Devices for in Vitro Diagnostics and Recent Changes in the Legislation of the Russian Federation

Key Points

The registration process for medical devices in Russia is complex and challenging for manufacturers due to unclear logistics.
Recent legislative changes have introduced new requirements for in vitro diagnostics registration, complicating compliance.
Manufacturers often need assistance from third-party organizations to navigate the registration hurdles involved.
A complete understanding of the current registration process in Russia is essential for effective use of in vitro diagnostics.

Abstract

Medical devices for in vitro diagnostics (herein after referred to as MDID) play one of the key roles in the field of healthcare, allowing the diagnosis of various diseases, monitoring the state of health and choosing the most effective treatment strategy. However, in order for such products to be used in medical practice in the Russian Federation, they must undergo a complex registration procedure. Today, registration procedures and rules have been developed in the Russian Federation, but the logistics of these events are not always clear to manufacturers, and there are many difficulties and difficulties along the way that cannot be overcome without the help of third-party organizations. In addition, new legislative acts have been issued in recent years, which must be taken into account when registering MD ID in the Russian Federation. Therefore, obtaining a complete picture based on new data is a complex procedure, the presentation of the stages of which is necessary to understand the process itself.

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